Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Diseases

Pancreatic Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Pembrolizumab

Cisplatin

Immunomodulating Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will receive treatment on Day 1 and Day 8 of each cycle. Gemcitabine (1000 mg/m2) will be administered IV on Day 1 and Day 8 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and then 4-6 cycles after surgery.

Patients will receive treatment on Day 1 and Day 8 of each cycle. Cisplatin (25 mg/m2) will be administered IV on Day 1 and Day 8 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and then 4-6 cycles after surgery.

Patients will receive treatment on Day 1 of each cycle. Pembrolizumab (200 mg) will be administered IV on Day 1 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and then 4-6 cycles after surgery. Pembrolizumab (400 mg) will be administered IV Q6 weeks up to 4 cycles as maintenance.

Colleen Apostal, RN

Joann Santmyer, RN

Colleen Apostol, RN

Marina Baretti, MD

Marina Baretti, M.D.

The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.

Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

The evaluable population of this endpoint consist of all patients who receive at least one dose of study drug and have TAMs and CD8 T cell measures at the time of surgery. TAMs being evaluated are the following: immunosuppressive TAMs with high Arginase-1 expression (CD68+CD163+Arg-1hiPDL1-/+), immunosuppressive TAMs with low Arginase-1 expression (CD68+CD163+Arg-1lo PDL1-/+), and less immunosuppressive TAMs (CD68+CD163-HLA-DRhi/CD86hi/PDL1hi)

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.

Extended treatment delay is defined as a delay of greater than 60 days of the pre-planned surgical evaluation date, or inability to go to surgery due to an adverse event related to study treatment.

The number of participants with a major pathologic response as defined by ≤ 10% residual viable tumor cells in the resection of the primary tumor and lymph nodes.

The number of participants with a R0 resection as defined by a microscopically margin-negative resection, in which no tumor (gross or microscopic) remains in the primary tumor bed.

Merck Sharp & Dohme LLC

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Fluorouracil

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib

Adebrelimab

Hepatic Arterial Infusion Chemotherapy

Yubao Zhang, MD

This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer.

This study plans to recruit 30 patients with borderline resectable, locally advanced biliary tract cancer who have not received treatment， abserve and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib.

HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study

Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.

Proportion of patients who can undergo surgical resection among all enrolled patients

The proportion of patients whose tumor volume shrinks to a predetermined value and can maintain the minimum time limit, which is the sum of the proportions of complete remission and partial remission.

After preoperative treatment and surgery, there are no residual viable tumor cells in the tumor bed in the postoperative specimen (%RVT=0)

After preoperative treatment and surgery, the proportion of residual viable tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10% (%RVT≤10)\*

Duration from surgical resection to first recurrence or death from any cause

Overall survival is measured from the first dose of study drug until death from any cause.

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers	NCT06001658	Pancreatic Canc...	Gemcitabine Cisplatin Pembrolizumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer	NCT06389500	Biliary Tract C...	Adebrelimab Lenvatinib Hepatic Arteria...	18 Years - 75 Years	Harbin Medical University
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers	NCT06001658	Pancreatic Canc...	Gemcitabine Cisplatin Pembrolizumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for potentially resectable biliary tract cancer